Kornimate/medical-research-clean huggingface dataset:
a phase ii study of amifostine for the prevention of acute radiation-induced rectal toxicity

Conditions: Rectal Cancer

Summary: the purpose of this study is to evaluate the effect of intrarectal amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

to evaluate the different use way of intrarectal amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Eligibility criteria:
inclusion criteria: * pathologically confirmed rectal cancer, preoperative stage ii / iii (t3-4n0 or t1-4n + m0). * tumor distance from anus less than 12 cm. * kps score not less than 70 * can be tolerated chemotherapy and radiotherapy. * pelvic who had no history of radiation therapy. * non-allergic history of fluorouracil or platinum-based chemotherapy drugs. * blood pressure can be controlled by drugs in the normal range (90 ≤ systolic blood pressure ≤ 140,60 ≤ diastolic blood pressure ≤ 90). * a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. exclusion criteria: * other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous). * pregnant or lactating patients. * fertility but did not use contraceptive measures. * existing active infection. * merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension. * concurrent treatment with other anticancer drugs. * can not complete treatment or follow-up.

Keywords: rectal cancer amifostine pre-operative chemo-radiation
a randomized controlled trial on egbd vs pc for acute cholecystitis.

Conditions: Acute Cholecystitis

Summary: acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for surgery. percutaneous cholecystostomy (pc) is frequently employed for gallbladder drainage in these patients. recently, the feasibility of eus-guided gallbladder drainage (egbd) in treatment of this condition has been demonstrated but how the two procedures compare to one another is uncertain. the aim of this study is to compare egbd versus pc as a definitive treatment, in high-risk patients suffering from acute cholecystitis in a randomized controlled trial. we hypothesize that egbd can reduce the morbidity, re-intervention and mortality when compared to pc.


Eligibility criteria:
inclusion criteria: * consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions including: american society of anesthesiology grading ≥ 3, apache score ≥ 12, limited life expectancy (less than 2 years) or deemed unsuitable for general anesthesia would be included. * written informed consent from patient or guardian who is able to understand the nature and possible consequences of the study exclusion criteria: * pregnancy * patients unwilling to undergo follow-up assessments * patients with suspected gangrene or perforation of the gallbladder * patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal) * altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum * patients with liver cirrhosis, portal hypertension and/or gastric varices * abnormal coagulation: inr \> 1.5 and/or platelets \< 50.000/mm3 * previous drainage of the gallbladder

Keywords: acute cholecystitis eus-guided gallbladder drainage percutaneous cholecystostomy
fetal programming of obesity

Conditions: Healthy; Pregnancy

Summary: the overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

the purpose of this study is to determine how the mother's health prior to or at the beginning of pregnancy may influence her child's growth and development. we plan to: 1) longitudinally and simultaneously assess a true measure of body composition (lean and fat mass) of the offspring, assess body composition of both parents, and obtain dietary intake data of the mother and offspring; 2) determine endocrine and metabolic profiles of the mother at baseline (pre-conception), during pregnancy and at birth (such as insulin, glucose, leptin); 3) determine the energy expenditure and physical activity of the mother and the child; 4) determine gene expression of the placenta and umbilical cord via gene microarray and real time pcr; and 5) focused on appropriate-for-gestational age (aga) infants (the majority of infants born from normal and overweight mothers).accordingly, this study will provide much needed comprehensive information on the possible effect of fetal programming on the development of pediatric obesity.

Eligibility criteria:
inclusion criteria: * healthy * 21 years of age or older * second pregnancy, singleton * conceived without fertility treatments exclusion criteria: * preexisting medical conditions * sexually transmitted diseases * medical complications during pregnancy * medications during pregnancy known to influence fetal growth * smoking, alcohol drinking * excessive physical activity level which could affect the outcome of interest.

Keywords: healthy women pregnancy
a single dose study of pf-04620110 in healthy subjects

Conditions: Healthy

Summary: pf-04620110 is a novel compound proposed for the treatment of type 2 diabetes mellitus. the primary purpose of this trial is to evaluate the relative bioavailability of three different oral dose formulations of pf-04620110.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Keywords: single dose study in healthy subjects
pro-state:search for a protein profile corresponding to fast-developing lesions and characterization of implicated proteins in prostate carcinoma

Conditions: Adenoma, Prostatic

Summary: the main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins.

in men, prostate carcinoma is the first cancer and the second cause of death by cancer. it is a slowly evolving disease with no prognostic marker of poor outcome. currently, the prostate specific antigen (psa) is the only available biological marker. it is a tissue marker and not a tumoral pathology control. this is why new tissue markers are urgently needed to select patients with unfavourable evolution, in order to treat them rapidly by more effective methods such as chemotherapy, hormonotherapy or radiotherapy. this could improve survival time and quality of life. proteomic and clinical data comparison could point to new relevant molecules and permit the development of new biological tests for routine use. seldi-tof-ms (surface enhanced laser desorption/ionisation mass spectrometry) permits an extremely sensitive analysis of proteins. this method has been substantially ratified by the literature and a number of markers have already been identified, particularly for several cancer pathologies. as far as prostate carcinomas are concerned, previous proteomic researches on serum have led to diagnostic parameters, differentiating healthy patients, patients with benign lesion and patients having malignant lesions. however, at present, no relevant protein has been identified. moreover, no study has been carried out to characterize fast-developing lesions, in order to anticipate response to treatments. the main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins. the main judgement criteria will be intensity peaks in the protein profile (area and height) with reference to combined criteria (psa rate, clinical stage, gleason score). two groups will be compared: * group 1: control (negative biopsy). * group 2: prostate carcinoma (positive biopsy). this group will be subdivided: * group 2a : favourable prognostic according to amico classification * group 2b : intermediate or unfavourable prognostic according to amico classification this will contribute to setting up an aftercare database combining clinical data with biological data and protein profile.

Eligibility criteria:
inclusion criteria: * patient undergoing a prostate biopsy or a prostatectomy(according to common criteria). exclusion criteria: * patient refusing to take part in the study.

Keywords: adenoma, prostatic prostate proteomics urology
spectral ct in radiotherapy for cervical cancer

Conditions: Cervical Cancer; Radiotherapy

Summary: the purpose of this study was to explore the potential application of spectral ct for radiotherapy in cervical cancer.


Eligibility criteria:
inclusion criteria: 1. all patients were confirmed cervical cancer by pathology 2. patients were treated with concurrent chemoradiotherapy 3. spectral ct scans acquisition performed during the arterial phase and venous phase 4. all the patients underwent a 18f-fdg pet/ct before treatment exclusion criteria: 1. ct without spectral scans 2. history of allergy to intravenous contrast 3. pregnant or potentially pregnant female subjects
multiple myeloma and exercise

Conditions: Newly Diagnosed Multiple Myeloma

Summary: this study will establich the feasibility of weight lifting exercise among patients with multiple myeloma, determine if weight lifting exercise increases lean body mass among patients with multiple myeloma and obtain further preliminary data on toxicity and pharmacokinetics of high-dose melphalan.

this is a prospective, single-institution, pilot study of a 3 month weight lifting program designed to increase musle hypertrophy prior to starting stem cell collection and receiving high-dose melphalan, in patients with multiple myeloma. we will use this exercise intervention while patients are receiving initial induction chemotherapy in the 3-6 month period before they receiv high-dose melphalan. the primary study endpoint is to determine the feasibility of recruiting and retaining multiple myeloma patients to an exercise intervention trial. the secondary study endpoint is to determine whether the weight lifting program increases lean body mass as intended.

Eligibility criteria:
inclusion criteria: * histologically confirmed multiple myeloma * 1 year since start of treatment for myeloma * patient and treating physician in agreement to proceed with autologous transplant, with a planned time betwwen study enrollment and transplant of 10 weeks * age 18 years. * able to walk for 6 minutes unaided. * body mass index 50 kg/m2 * serum creatinine 2.5 mg/dl * ability to understand the informed consent document and willingness to consent. written informed consent must be obtained from all patients before study entry. exclusion criteria: * recent (in the past 6 months) participation in progressive weight lifting exercises or who already exercise regulary (3 times a week of moderate intensity aerobic exercise). * plan to move out of the area during the study intervention. * a psychological, social, or logistical barrier that the principal investigators feel would preclude completion of the study protocol. * plan for use of any anti-myeloma treatment other than melphalan (the use of total body irradiation will not
equivalence study of dorzolamide 2% eye drops solution

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. for this purpose the patients are randomized into two sequences of study drug administration in a crossover study with an adequate wash-out period.


Eligibility criteria:
inclusion criteria: * male or female patients of any race aged 18 years or older * a clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes * iop controllable on one drug treatment in the study eye in way that assures clinical stability of vision and the optic nerve throughout the study * baseline iop between 18 and 32 mmhg in the study eye (in eyes not included in the study iop must have been controllable on no pharmacologic treatment or on the study medicine only) * best corrected visual acuity of 20/200 or better in the study eye(s) * ability of subject to understand character and individual consequences of clinical trial * signed and dated informed consent of the subject must be available before start of any specific trial procedures * women with childbearing potential have to practicing a medically accepted contraception during trial and a negative pregnancy test (serum or urine) should be existent before trial. reliable contraception are systemic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicidal. women that are sterile by surgery or for more than two years postmenopausal can be participate in the trial. exclusion criteria: * chronic or recurrent inflammatory eye disease * ocular trauma within the past six months * current ocular infection, i.e. conjunctivitis or keratitis * any abnormality preventing reliable applanation tonometry * intraocular surgery or laser treatment within the past three months * inability to discontinue contact lens wear during the study * use of any systemic medication that would affect iop with less than a 1-month stable dosing regimen before the screening visit * pregnancy and lactation * history of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product * participation in other clinical trials during the present clinical trial or within the last four weeks * medical or psychological condition that would not permit completion of the trial or signing of informed consent * subject is allergic to sulfonamides * severe renal dysfunction or hyperchloraemic acidosis

Keywords: equivalence study eye drops solution dorzolamide open angle glaucoma ocular hypertension
safety, efficacy and pharmacokinetic study of allegra in pediatric patients with perennial allergic rhinitis (par)

Conditions: Rhinitis Perennial

Summary: primary objective: - to evaluate safety (4 weeks) secondary objectives: * to evaluate the long-term safety (12 weeks) * to evaluate the efficacy * to characterize the pharmacokinetic profile

the study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Eligibility criteria:
inclusion criteria: * aged 6 months through 11 years * patients with perennial allergic rhinitis exclusion criteria: * neither serum specific ige antibody or skin reaction is positive for the antigen of perennial allergy. * nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4. * patients with vasomotor rhinitis or eosinophilic rhinitis. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effects of nalmefene after single dose on the blood oxygen level dependent (bold) fmri signal in the ventral striatum to reward responding in the monetary incentive delay task (midt), in non-treatment seeking subjects with alcohol dependence following alcohol challenge

Conditions: Alcohol Dependence

Summary: to contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene


Eligibility criteria:
inclusion criteria: * the subject has alcohol dependence, diagnosed according to dsm-iv-tr™. exclusion criteria: * the subject is seeking treatment for alcohol dependence. * the subject has had \<6 heavy drinking days (hdds) in the 4 weeks prior to the screening visit. * the subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) \<4 weeks prior to the screening visit. * the subject has \>5 consecutive abstinence days in the 4 weeks prior to the screening visit. * the subject has a revised clinical institute withdrawal assessment of alcohol scale, (ciwa-ar), score ≥10. * the subject is, in the opinion of the investigator, at significant risk of suicide or meets the exclusion criteria based on c-ssrs. other inclusion and exclusion criteria may apply.
reliability and validity of the six-spot step test after total hip arthroplasty

Conditions: Total Hip Replacement; Reproducibility of Results; Rehabilitation

Summary: this study aims to assess the ssst's validity, reliability, and ability to differentiate between high and low fall risk individuals in tha patients. establishing the ssst as a valid and reliable tool will help manage rehabilitation and apply timely interventions for tha patients.

total hip arthroplasty (tha) is a common surgery for patients with advanced hip osteoarthritis, aiming to reduce pain and improve function. however, tha patients often experience difficulties in mobility tasks, such as walking, stair climbing, and standing up, even years after surgery. these functional impairments increase the risk of falls, highlighting the need for effective clinical tests to assess balance and mobility. identifying factors contributing to balance dysfunction and implementing appropriate rehabilitation are crucial for improving quality of life. the six-spot step test (ssst), developed by nieuwenhuis et al., is a quick and easy test that evaluates balance and mobility in daily life activities. however, its validity and reliability in tha patients have not been studied. this research aims to assess the ssst's validity, reliability, and ability to differentiate between high and low fall risk individuals in tha patients. establishing the ssst as a valid and reliable tool will help manage rehabilitation and apply timely interventions for tha patients.

Eligibility criteria:
inclusion criteria: * underwent primary unilateral total hip arthroplasty (tha) * surgery performed using the posterolateral approach * at least six months of postoperative follow-up exclusion criteria: * patients who underwent bilateral or revision tha * history of additional lower limb surgery * body mass index (bmi) greater than 40 kg/m² * neurological, orthopedic, or systemic disorders that could impair gait or balance
ejaculatory sparing transurethral incision of the prostate (es-tuip) versus conventional tuip

Conditions: Prostate Hyperplasia; Transurethral Incision Of The Prostate; Ejaculatory Dysfunction

Summary: in this study, investigators planned to compare ejaculatory sparing and non-ejaculatory sparing (conventional) tuip using both subjective and objective assessment tools for the degree of deobstruction. furthermore, the impact of both techniques on ejaculation and its secondary effect on orgasm perception and different domains of sexual function will be thoroughly assessed.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) score ≤3. * trus estimated prostate weight ≤ 35 grams. * sexually interested and having continuous relationship with the same partner (interested). * bladder outlet obstruction index (booi ) ≥ 20 as per pressure flow study exclusion criteria: * preoperative sexual or ejaculatory disturbances or pelvic pain syndrome * neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled diabetes mellitus (dm) type 2 (\> 10 years), dm type 1, cerebral stroke, parkinsonism * urodynamic changes consistent with urethropathy or detrusor hypocontractility * previous pelvic surgeries or radiotherapy

Keywords: transurethral incision of the prostate prostate ejaculatory sparing
ringing a bell on the final day of radiation therapy in improving the memory of distress in cancer patients

Conditions: Distress; Malignant Neoplasm

Summary: this clinical trial studies how well ringing a bell on the final day of radiation therapy works in improving the memory of distress in cancer patients. ringing a bell on the final day of radiation therapy may improve the memory of how painful the treatment was.

primary objectives: i. to determine if the simple act of ringing a bell at the end of radiotherapy can improve the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy. secondary objectives: i. to measure the severity of patients' memory of distress from cancer treatment. ii. to assess the relationship between anxiety to actual distress and to remembered distress. iii. to assess the relationship between optimism-pessimism personality to actual distress and to remembered distress. iv. to assess patient's cognitive dissonance reduction to actual distress and to remembered distress. outline: patients are assigned to 1 of 2 groups. group a (no bell ringing): patients undergo standard of care radiation therapy with or without chemotherapy. group b (bell ringing): on the final day of standard of care radiation therapy, patients ring a bell in the clinic. after completion of study, patients are followed up for 7 months.

Eligibility criteria:
inclusion criteria: * diagnosis of cancer * definitive radiation treatment with or without concurrent chemotherapy with curative intent; treatment prior to radiation therapy is acceptable (e.g. surgery, chemotherapy) * ability to understand and the willingness to sign a written informed consent; consents will be provided in english or spanish * able to speak english or spanish (questionnaires will be in english and spanish) exclusion criteria: * patients with either a malignant central nervous system (cns)-primary cancer or with brain metastases; patients do not need to undergo brain imaging unless indicated per standard workup and management (e.g. advanced stage lung cancer receiving definitive therapy) * patients who will be receiving surgery or adjuvant chemotherapy within 1 month following radiation treatment * patients with widespread metastatic disease (\> 3 distant metastases); patients with oligometastatic disease (=\< 3 distant metastases) are allowed only if they are receiving definitive (curative) radiation therapy (rt) with or without chemotherapy
maveric magnetic resonance imaging used to study detailed bone apposition and fixation of the stryker trident ii tritanium system

Conditions: Chronic Hip Pain

Summary: the study aims to describe bone apposition and fixation of the trident and trident ii tritatnium acetabular system in patients 1 year status post total hip replacement. we will be studying this by comparing magnetic resonance imaging (mri)s taken 1 year s/p total hip replacement with a trident ii cup with mri's taken of patients with the trident cup who had mris done at 1 year post-op.


Eligibility criteria:
inclusion criteria: 1. patients who had a primary total hip replacement with a stryker trident ii acetabular cup that have one year or more follow up. 2. patients that are willing able able to have an mri at their one year follow up visit. 3. patients entered into the corre database (our hss institutional joint replacement registry). exclusion criteria: 1. patients who have not been consented as part of the corre database. 2. patients who are unable or refuse to have an mri at their 1 year follow up.

Keywords: bone apposition stryker mri trident ii total hip replacement